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Archives for October 2013

Cardiac Biomarker ST2 Proves Far Superior To Galectin-3 In A Head-to-Head Study

Critical Diagnostics recently announced that the study, “Head-to-head comparison of two myocardial fibrosis biomarkers for long-term heart failure risk stratification: ST2 vs. Galectin-3”, recently published online in JACC (the Journal of the American College of Cardiology) comparing the company’s novel cardiac biomarker ST2 to Galectin-3 (Gal-3), a biomarker from BG Medicine (NASDAQ: BGMD), found ST2 to be superior.

FDA Grants Genentech’s Perjeta Accelerated Approval for Use Before Surgery in People With HER2-Positive Early Stage Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), recently announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. This approval is based primarily on data from a Phase II study showing that nearly 40 percent of people receiving the combination of Perjeta, Herceptin® (trastuzumab) and docetaxel chemotherapy had no evidence of tumor tissue detectable at the time of surgery (known as a pathological complete response, or pCR). The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the FDA and also the first to be approved based on pCR data.

Multiplicom Launches Three New Mutation Detection Kits to Enable the Implementation of Personalized Cancer Treatment

Multiplicom NV, a specialist in the development, production and commercialization of innovative molecular genetic tests based on massively parallel sequencing (MPS), recently announced that it is launching three new somatic mutation detection kits which will enable users to implement personalized cancer treatment at an unprecedented level.

Evidence-Guided Molecular Profiling Offers New Hope for Oncologists Managing Difficult-to-Treat Cancers

Caris Life Sciences recently announced data from two studies presented at the 2013 European Cancer Congress (ECC 2013), which demonstrate the potential of evidence-guided molecular profiling to improve the treatment of patients with hard-to-treat cancers, including cancers of unknown primary (CUP) origins as well as rare tumors and cancers that have been refractory to treatment.

New Study Shows Circulating Tumor Cell Enumeration – as Part of Composite Biomarker Panel – May Serve as a Surrogate for Efficacy Response in Metastatic Castration-Resistant Prostate Cancer

Janssen Diagnostics, LLC recently announced results from a study presented at the European Cancer Congress in Amsterdam, Netherlands, that demonstrated circulating tumor cell (CTC) enumeration using CELLSEARCH®, along with lactate dehydrogenase (LDH) as part of a composite biomarker panel, was an efficacy-response surrogate for survival in managing patients with metastatic castration-resistant prostate cancer (mCRPC). The results show mCRPC patients with greater than or equal to five CTCs and an abnormal LDH level at 12 weeks of treatment have a poorer prognosis than those with lower CTC counts and normal LDH values, with a one- and two-year survival probability of 25 percent and 2 percent compared to 82 percent and 46 percent, respectively. Findings suggest therapeutic alternatives should be considered for patients in the high-risk category at 12 weeks.